Evaluation of the Pharmacokinetic Interaction Between Candesartan and Felodipine After Ingestion of a Specific Meal
![]() |
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT00905333 |
Recruitment Status :
Completed
First Posted : May 20, 2009
Last Update Posted : December 7, 2010
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Healthy | Drug: Candesartan (test) Drug: Felodipine (test) Drug: Candesartan Cilexetil Drug: Felodipine | Phase 1 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 36 participants |
Intervention Model: | Crossover Assignment |
Masking: | None (Open Label) |
Official Title: | Evaluation of the Pharmacokinetic Interaction Between Candesartan and Felodipine in a Combination Package Compared to the Separate Intake of the Reference Brands Atacand and Splendil After a Fasting Period. |
Study Start Date : | October 2008 |
Actual Primary Completion Date : | November 2008 |
Actual Study Completion Date : | November 2008 |

Arm | Intervention/treatment |
---|---|
Single-arm
3 treatments, 6 sequences, 3 periods, cross-over, single dose arm (Willians' Plan)
|
Drug: Candesartan (test)
16 mg oral tablet, single dose Drug: Felodipine (test) 5 mg oral extended release tablet, single dose Drug: Candesartan Cilexetil 16 mg oral tablet, single dose
Other Name: Atacand® Drug: Felodipine 5 mg oral extended release tablet, single dose
Other Name: Splendil® |
- Kinetic interaction evaluation of two test formulations of 16 mg of candesartan and 5 mg of felodipine after a fasting period and the comparison with the intake of both reference medicaments: Atacand® and Splendil®. [ Time Frame: 76 blood samples per subject ]

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years to 50 Years (Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
- Healthy volunteers
- BMI > or = 19 and < or = 28 (Dietary Guidelines Advisory Committee, 2005)
Exclusion Criteria:
- Not healthy
- Chronic drug intake

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00905333
Brazil | |
Research Site | |
Itatiba, SP, Brazil | |
Research Site | |
Americana, Brazil |
Principal Investigator: | Eduardo Abib Junior, MD | Scentryphar Clinical Research | |
Study Chair: | Moises L. P Vanuncci, MD | Scentryphar Clinical Research |
Responsible Party: | MC MD, AstraZeneca |
ClinicalTrials.gov Identifier: | NCT00905333 |
Other Study ID Numbers: |
D2452L00021 IMPACT 15381 |
First Posted: | May 20, 2009 Key Record Dates |
Last Update Posted: | December 7, 2010 |
Last Verified: | December 2010 |
pharmacokinetics candesartan felodipine test formulations Atacand® |
Splendil® healthy volunteers blood samples after meal intake interaction Kinetic interaction amongst test formulations of Candesartan and Felodipine and the brands Atacand® and Splendil® in healthy volunteers after a fasting period. |
Felodipine Candesartan Candesartan cilexetil Antihypertensive Agents Angiotensin II Type 1 Receptor Blockers Angiotensin Receptor Antagonists Molecular Mechanisms of Pharmacological Action |
Anti-Arrhythmia Agents Calcium Channel Blockers Membrane Transport Modulators Calcium-Regulating Hormones and Agents Physiological Effects of Drugs Vasodilator Agents |